(268 days)
MaxiTears® CONTACTS PF eye drops have been formulated for use with both soft and rigid gas permeable (RGP) contact lenses, to rewet lenses before insertion and lubricate lenses during wear. It also relieves minor irritation, discomfort, dryness, blurring and itchiness, which may occur while wearing your lenses.
The MaxiTears CONTACTS PF are ready-to-use, isotonic, sterile eye contact lens care products (lubricants) intended to moisturize and lubricate the lens drops in eyes to reduce minor symptoms of dry eyes such as burning or itching. The intended use of these contact lens rewetting solutions is to alleviate the symptoms of dryness, discomfort, and minor irritation caused by ocular fatigue induced by the wearing of contact lenses, for example, by environmental conditions (dust, smoke, dry heat, air conditioning, wind, cold) tiredness or extended computer screen use. The MaxiTears CONTACTS PF solution can be used with all types of contact lenses, except contact lenses manufactured from Efrofilcon A, and are intended for repeated use over an extended period of time.
The MaxiTears CONTACTS PF solution it to be introduced to the US-market as an Over the Counter (OTC) medical device similar to other 510k-cleared lens drop lubricants (and identical to predicate Blink CL Lubricant Eve Drops K032030), sold as OTC medical device in retail outlets and through the internet.
OmniVision AG is offering the MaxiTears CONTACTS PF solution as Over the Counter device:
- MaxiTears' CONTACTS PF is a medium viscous preservative-free solution packaged in single-use . ampoules (single-dose units -SDU). They are supplied as single-dose unit plastic ampoules designed to administer one drop and then to be discarded. They are indicated for users with a known history of allergy to preservatives and those who wear contact lenses.
The provided text is a 510(k) summary for MaxiTears® CONTACTS PF, an over-the-counter eye drop. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.
Instead, the submission primarily focuses on demonstrating non-clinical equivalence to a predicate device (blink™ CL Lubricant Eye Drops) through various performance tests and material comparisons.
Therefore, I cannot provide the requested information for an AI/ML device, as the document explicitly states:
- "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." (Section 10. Clinical Performance Data)
- "The non-clinical testing detailed in this submission supports the substantial equivalence of the device." (Section 10. Clinical Performance Data)
This submission is for a contact lens care product (eye drops), not an AI/ML medical device. Hence, the questions related to AI/ML device validation (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to the content provided.
§ 886.5918 Rigid gas permeable contact lens care products.
(a)
Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”